Prospective Study on the Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- adverse event related to booster shot
研究概览
简要总结
The current study is a noninterventional prospective study examining the efficacy of additional dosage of the coronavirus disease 2019 (COVID-19) vaccine in kidney transplant recipients (KTRs).
详细描述
In this clinical, prospective, non-interventional study to assess the effectiveness of an additional dose of COVID-19 vaccination, we evaluated the seroconversion rate of KTRs after the booster shot. Consecutive individuals who have completed standard two-doses of COVID-19 vaccination were enrolled. Following consent, demographic and clinical data were collected from participants, including patient/ transplant characteristics and information regarding previous COVID-19 vaccination.
1 Study visit and sample collection Patients were invited to return for up to 2 follow-up visits for sample collection. Whole blood samples were collected two weeks to 1 day before the booster vaccination and 4 weeks after. During the visit for the second blood sample, a survey was conducted to assess booster-related adverse events.
- Anti-SARS-CoV-2 antibody assay IgG antibodies against the receptor-binding domain (RBD) of the S1 subunit of the spike protein of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) were quantified with SARS-CoV-2 IgG II Quant assay (Abbott).
Additionally, neutralizing antibody was assessed using anti-SARS-CoV-2 GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit. The cPass detection kit utilizes the horseradish peroxidase (HRP) conjugated recombinant SARS-CoV-2 RBD protein and the human angiotensin-converting enzyme 2 (ACE2) receptor protein. It detects neutralizing antibodies capable of blocking protein interaction between HRP-RBD and ACE2. The assay was performed according to the manufacturer's instructions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received kidney-only transplantation or multi-organ transplantation including kidney before December 31, 2020
- •Patients ≥ 12 years old
- •Patients fully vaccinated with two standard doses of COVID-19 vaccination with the vector vaccine (AZD1222 of AstraZeneca) or the mRNA vaccines (BNT162b2 of Pfizer-BioNTech or mRNA-1273 of Moderna) including homologous and heterologous regimen.
- •Patients with plans of getting an additional dose of COVID-19 vaccine (i.e., booster shot)
- •Patients providing informed consent and willing to comply with the study protocol, including two blood tests and a survey.
排除标准
- •Patients with a previous history of SARS-CoV-2 infection
- •Who had B-cell depleting therapy (e.g., rituximab, bortezomib) or T-cell depleting therapy (anti-thymocyte globulin) within six months
- •Patients who restarted dialysis due to graft failure
研究组 & 干预措施
Kidney transplant recipients with booster
Patients who received kidney-only transplant or multi-organ transplant including kidney and fully vaccinated with standard dose(s) of messenger RNA (mRNA) or vector vaccine
干预措施: COVID-19 vaccine, booster (Drug)
结局指标
主要结局
adverse event related to booster shot
时间窗: 1 month after booster vaccination
local and systemic adverse event related to the third dose of COVID-19 vaccine
anti-SARS-CoV-2 IgG antibody seroconversion rate
时间窗: 1 month after booster vaccination
Seroconversion rate calculated from the anti-SARS-CoV-2 IgG antibody positivity difference before and after the booster shot
次要结局
- Rate of anti-SARS-CoV-2 IgG positivity after standard 2-doses of COVID-19 vaccine(2week before booster vaccination)
- Rate of neutralization antibody positivity after standard 2-doses of COVID-19 vaccine(2week before booster vaccination)
- Rate of neutralization antibody after additional third doses of COVID-19 vaccine(1 month after booster vaccination)
- Rate of neutralization antibody seroconversion rate upon third doses of COVID-19 vaccine(1 month after booster vaccination)
- Change in the quantitative amount of IgG after additional third doses of COVID-19 vaccine(1 month after booster vaccination)
- Rate of anti-SARS-CoV-2 IgG positivity after additional third doses of COVID-19 vaccine(1 month after booster vaccination)
研究者
Jongwon Ha
Professor
Seoul National University Hospital